Adrianne C. Feldstein

Randomized Trial of Effect of Alendronate Continuation Versus Discontinuation in Women With Low BMD: Results From the Fracture Intervention Trial Long-Term Extension

To determine the effects of continuation versus discontinuation of alendronate on BMD and markers of bone turnover, we conducted an extension trial in which 1099 older women who received alendronate in the FIT were re‐randomized to alendronate or placebo. Compared with women who stopped alendronate, those continuing alendronate for 3 years maintained a higher BMD and greater reduction of bone turnover, showing benefit of continued treatment. However, among women who discontinued alendronate and took placebo in the extension, BMD remained higher, and reduction in bone turnover was greater than values at FIT baseline, showing persistence of alendronates effects on bone.

A Practical, Robust Implementation and Sustainability Model (PRISM) for Integrating Research Findings into Practice

BACKGROUND Although numerous studies address the efficacy and effectiveness of health interventions, less research addresses successfully implementing and sustaining interventions. As long as efficacy and effectiveness trials are considered complete without considering implementation in nonresearch settings, the public health potential of the original investments will not be realized. A barrier to progress is the absence of a practical, robust model to help identify the factors that need to be considered and addressed and how to measure success. A conceptual framework for improving practice is needed to integrate the key features for successful program design, predictors of implementation and diffusion, and appropriate outcome measures. DEVELOPING PRISM A comprehensive model for translating research into practice was developed using concepts from the areas of quality improvement, chronic care, the diffusion of innovations, and measures of the population-based effectiveness of translation. PRISM--the Practical, Robust Implementation and Sustainability Model--evaluates how the health care program or intervention interacts with the recipients to influence program adoption, implementation, maintenance, reach, and effectiveness. DISCUSSION The PRISM model provides a new tool for researchers and health care decision makers that integrates existing concepts relevant to translating research into practice.

Efficacy of continued alendronate for fractures in women with and without prevalent vertebral fracture: The FLEX Trial

In the Fracture Intervention Trial (FIT) Long Term Extension (FLEX) Trial, 10 years of alendronate (ALN) did not significantly reduce the risk of nonvertebral fractures (NVFs) compared with 5 years of ALN. Continuing ALN reduced the risk of clinical but not morphometric vertebral fractures regardless of baseline vertebral fracture status. In previous studies, ALN efficacy for NVF prevention in women without prevalent vertebral fracture was limited to those with femoral neck (FN) T‐scores of −2.5 or less. To determine whether the effect of long‐term ALN on fracture differs by vertebral fracture status and femoral neck (FN) T‐score, we performed a post hoc analysis using FLEX data, a randomized, double‐blind, placebo‐controlled trial among 1099 postmenopausal women originally randomized to ALN in the FIT with mean ALN use of 5 years. In the FLEX Trial, women were randomized to placebo (40%) or ALN 5 mg/day (30%) or ALN 10 mg/day (30%) for an additional 5 years. Among women without vertebral fracture at FLEX baseline (n = 720), continuation of ALN reduced NVF in women with FLEX baseline FN T‐scores of −2.5 or less [relative risk (RR) = 0.50, 95% confidence interval (CI) 0.26–0.96] but not with T‐scores of greater than −2.5 and −2 or less (RR 0.79, 95% CI 0.37–1.66) or with T‐scores of greater than −2 (RR 1.41, 95% CI 0.75–2.66; p for interaction = .019). Continuing ALN for 10 years instead of stopping after 5 years reduces NVF risk in women without prevalent vertebral fracture whose FN T‐scores, achieved after 5 years of ALN, are −2.5 or less but does not reduce risk of NVF in women whose T‐scores are greater than −2.

Electronic medical record reminder improves osteoporosis management after a fracture: a randomized, controlled trial.

OBJECTIVES: Osteoporosis treatment rates after a fracture are low. This study evaluated methods to increase guideline‐recommended osteoporosis care postfracture.

Incidence and demography of femur fractures with and without atypical features.

The case definition, community incidence, and characteristics of atypical femoral shaft fractures (FSFs) are poorly understood. This retrospective study utilized electronic medical records and radiograph review among women ≥50 years of age and men ≥65 years of age from January 1996 to June 2009 at Kaiser Permanente Northwest to describe the incidence rates and characteristics of subgroups of femur fractures. Fractures were categorized based on the American Society for Bone and Mineral Research (ASBMR) as atypical fracture major features (AFMs) (low force, shaft location, transverse or short oblique, noncomminuted) and AFMs with additional minor radiograph features (AFMms) (beaking, cortical thickening, or stress fracture). There were 5034 fractures in the study. The incidence rates of FSFs (without atypical features) and AFMs appeared flat (cumulative incidence: 18.2 per 100,000 person‐years, 95% CI = 16.0–20.7; 5.9 per 100,000 person‐years, 95% CI = 4.6–7.4; respectively) with 1,271,575 person‐years observed. The proportion of AFMs that were AFMms increased over time. Thirty percent of AFMs had any dispensing of a bisphosphonate prior to the fracture, compared to 15.8% of the non‐atypical FSFs. Years of oral glucocorticosteroid dispensing appeared highest in AFM and AFMm fractures. Those with AFMs only were older and had a lower frequency of bisphosphonate dispensing compared to those with AFMms. We conclude that rates of FSFs, with and without atypia, were low and stable over 13.5 years. Patients with only AFMs appear to be different from those with AFMms; it may be that only the latter group is atypical. There appear to be multiple associated risk factors for AFMm fractures.

Older Women with Fractures: Patients Falling Through the Cracks of Guideline-Recommended Osteoporosis Screening and Treatment

BACKGROUND Many older patients with fractures are not managed in accordance with evidence-based clinical guidelines for osteoporosis. Guidelines recommend that these patients receive treatment for clinically apparent osteoporosis or have bone mineral density measurements followed by treatment when appropriate. This cohort study was conducted to further characterize the gap between guidelines and actual practice with regard to bone mineral density measurement and treatment of older women after a fracture. Our purpose was to aid in the design of more effective future interventions. METHODS We identified female members of a not-for-profit group-model health maintenance organization who were fifty years of age or older and who had a diagnosis of a new fracture as defined in the study. We used administrative databases and the clinical electronic medical records to obtain data on demographics, diagnoses, drugs dispensed by the pharmacy, and the measurement of bone mineral density. RESULTS The study population included 3812 women with an average age of 71.3 years. Fewer than 12% of the women had a diagnosis of osteoporosis prior to the index fracture; 10.7% had an increased risk for secondary osteoporosis and 38.8%, for falls because of a diagnosis or medication. It was found that 46.4% of the study population had been managed as specified by clinical guidelines. The patients who had been managed as specified by the guidelines were younger and less likely to have the risk factor of a weight of <127 lb (58 kg), a hip fracture, or a wrist fracture. They were also more likely to be taking steroids on a chronic basis and to have had a vertebral fracture. The percentage of women who had measurement of bone mineral density increased during the study period, from 1.3% in 1998 to 10.2% in 2001. Of the patients receiving treatment for osteoporosis, 73.6% adhered to the treatment regimen. CONCLUSIONS Adherence to guidelines for evaluation and treatment for osteoporosis after a patient sustained a fracture did not improve between 1998 and 2001 despite the promulgation of evidence-based guidelines. Methods to enhance education and facilitate processes of care will be necessary to reduce this gap. It may be fruitful to target high-risk subgroups for tailored interventions for prevention of refracture.

Weight change in diabetes and glycemic and blood pressure control

OBJECTIVE—Weight loss in type 2 diabetes is undisputedly important, and data from community settings are limited. We evaluated weight change and resulting glycemic and blood pressure control in type 2 diabetic patients at an HMO. RESEARCH DESIGN AND METHODS—Using electronic medical records, this retrospective cohort study identified 2,574 patients aged 21–75 years who received a new diagnosis of type 2 diabetes between 1997 and 2002. We estimated 3-year weight trajectories using growth curve analyses, grouped similar trajectories into four categories using cluster analysis, compared category characteristics, and predicted year-4 above-goal A1C and blood pressure by group. RESULTS—The weight-trajectory groups were defined as higher stable weight (n = 418; 16.2%), lower stable weight (n = 1,542; 59.9%), weight gain (n = 300; 11.7%), and weight loss (n = 314; 12.2%). The latter had a mean weight loss of 10.7 kg (−9.8%; P < 0.001) by 18 months, with near-complete regain by 36 months. After adjusting for age, sex, baseline control, and related medication use, those with higher stable weight, lower stable weight, or weight-gain patterns were more likely than those who lost weight to have above-goal A1C (odds ratio [OR] 1.66 [95% CI 1.12–2.47], 1.52 [1.08–2.14], and 1.77 [1.15–2.72], respectively). Those with higher stable weight or weight-gain patterns were more likely than those who lost weight to have above-goal blood pressure (1.83 [1.31–2.57] and 1.47 [1.03–2.10], respectively). CONCLUSIONS—A weight-loss pattern after new diagnosis of type 2 diabetes predicted improved glycemic and blood pressure control despite weight regain. The initial period postdiagnosis may be a critical time to apply weight-loss treatments to improve risk factor control.

Health care utilization and costs by metabolic syndrome risk factors.

BACKGROUND This study compared prevalent health utilization and costs for persons with and without metabolic syndrome and investigated the independent associations of the various factors that make up metabolic syndrome. METHODS Subjects were enrollees of three health plans who had all clinical measurements (blood pressure, fasting plasma glucose, body mass index, triglycerides, and high-density lipoprotein cholesterol) necessary to determine metabolic syndrome risk factors over the 2-year study period (n = 170,648). We used clinical values, International Classification of Diseases, Ninth Revision (ICD-9) diagnoses, and medication dispensings to identify risk factors. We report unadjusted mean annual utilization and modeled mean annual costs adjusting for age, sex, and co-morbidity. RESULTS Subjects with metabolic syndrome (n = 98,091) had higher utilization and costs compared to subjects with no metabolic syndrome (n = 72,557) overall, and when stratified by diabetes (P < 0.001). Average annual total costs between subjects with metabolic syndrome versus no metabolic syndrome differed by a magnitude of 1.6 overall (

Potentially Inappropriate Medication Use by Elderly Persons in U.S. Health Maintenance Organizations, 2000–2001

5,732 vs.

Computerized Prescribing Alerts and Group Academic Detailing to Reduce the Use of Potentially Inappropriate Medications in Older People

3,581), and a magnitude of 1.3 when stratified by diabetes (diabetes,